The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. The TAILOR-DAPT trial aims to investigate the benefits of a score-based decision-making algorithm to guide DAPT duration compared to a standard-of-care DAPT duration without the use of risk scores in patients undergoing PCI.
PCI with drug eluting stent (DES) implantation
Age ≥18 years
Ability to sign informed consent before any study-specific procedure
Planned staged PCI (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop an indication for percutaneous valve intervention can undergo treatment 30 days after full coronary revascularization)
Indication for oral anticoagulation
Peri-procedural complication which affects DAPT regimen based on the operator's opinion (e.g. untreated flow-limiting angiographic complication, intraprocedural stent thrombosis, persistent vessel occlusion/no-reflow at the end of the procedure, major side-branch occlusion, puncture-site related or other relevant bleeding)
Treatment for stent thrombosis at qualifying PCI or within 1 year prior to qualifying PCI
Parallel
Algorithm-guided DAPT duration
Other interventionPRECISE-DAPT score ≥25 * Chronic Coronary Syndromes (CCS): Aspirin + clopidogrel for 1 month, followed by clopidogrel monotherapy * Acute Coronary Syndromes (ACS): Aspirin + ticagrelor for 1 month, followed by ticagrelor monotherapy PRECISE-DAPT score \<25: * Non-complex CCS: Aspirin + clopidogrel for 6 months, followed by clopidogrel monotherapy * Non-complex ACS: Aspirin + potent P2Y12 inhibitor for 6 months, followed by potent P2Y12 inhibitor monotherapy * Complex CCS or ACS: Aspirin + P2Y12 inhibitor for 12 months, followed by P2Y12 inhibitor monotherapy (potent P2Y12 inhibitor mandatory for ACS)
Standard-of-care DAPT duration
Other interventionDAPT strategy at the operators´ discretion in accordance with applicable guidelines
Net adverse clinical events (NACE)
All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding
Major adverse cardiovascular events (MACE)
Cardiovascular death, spontaneous myocardial infarction, definite stent thrombosis or stroke
Major or clinically relevant non-major bleeding
Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding
Major bleeding
Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding
Any Bleeding Academic Research Consortium (BARC) bleeding
Net adverse clinical events (NACE)
All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding
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